Recent Industry News

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued a report on the Office for Human Research Protections (OHRP) and its provision of whistleblower protection information. This OIG report was a companion to the OHRP report regarding the OHRP’s independence in carrying out its compliance activities for protecting human subjects. In this companion report, the OIG report found that the OHRP fails to provide such information to complainants who bring forth allegations of noncompliance with human subject protection regulations. OHRP is the HHS agency responsible for the protection of the rights, welfare, and well-being of subjects involved in HHS conducted or supported research. The agency receives and responds to alleged violations of protections for human subjects in research. Human research subjects and research institution employees making a “protected disclosure” may be entitled to “whistleblower protections” from a prohibited employment action (e.g., employee termination) by HHS contractors, subcontractors, and grantees. These complainants are in the best position to help identify noncompliance in human subject research. Their reporting can help to address any noncompliance, hold research institutions accountable, thereby ensuring public confidence in federally funded research. The OIG noted, however, that employees may fear reprisal, such as demotion, suspension, or termination, when considering whether to disclose information about potential noncompliance. As such, the OIG advised that provision of whistleblower protection information may encourage more noncompliance disclosures among potential complainants.

The OIG Investigates

The OIG analyzed files, documents, and other data on OHRP’s compliance activities from 2000-2015, to conduct their review. The reviewed data included descriptions of allegations that OHRP received, dates and sources of such allegations, and details of the OHRP’s resulting compliance activities. The OIG also reviewed OHRP’s administrative files from eight closed compliance evaluations and an open incident report. Additionally, the OIG conducted interviews with OHRP staff, HHS officials outside of OHRP, and individuals with expertise in protections for human subjects.

The OIG reported the following findings:

Complainants often request OHRP to provide them with whistleblower protections;

Some complainants choose not to report suspected noncompliance to OHRP, as the agency does not have the statutory authority to offer such protections; and

In four of the five OHRP evaluations reviewed, complainants had expressed a fear of reprisal.

The OIG recommended the following:

OHRP should inform complainants of how they may seek whistleblower protections by reporting their allegations of noncompliance with human subject protections to enforcement entities, such as the OIG or HHS agency funding the research;

OHRP should post whistleblower protection information prominently on the OHRP website and include it in its routine outreach to research institutions; and

HHS should consider the adequacy of whistleblower protections for those who make disclosures about human subject protections, and if needed, elevate this issue for further policy review that includes possible requesting of legislative change that enables OHRP and other HHS entities to receive protected disclosures.